药品注册申请号:018780
申请类型:BLA (生物制品许可申请)
申请人:LILLY
申请人全名:--
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 HUMULIN R INSULIN RECOMBINANT HUMAN INJECTABLE;INJECTION 100 UNITS/ML No No None 1982/10/28 -- Over-the-counter
002 HUMULIN R KWIKPEN INSULIN HUMAN SOLUTION;SUBCUTANEOUS 1500 UNITS/3ML (500 UNITS/ML) No No None -- Prescription
004 HUMULIN R INSULIN HUMAN SOLUTION;SUBCUTANEOUS 10000 UNITS/20ML (500 UNITS/ML) No No None -- Prescription
005 HUMULIN R PEN INSULIN RECOMBINANT HUMAN INJECTABLE;INJECTION 100 UNITS/ML No No None -- Over-the-counter
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2022/06/27 SUPPL-180(补充) Approval Labeling STANDARD Label for HUMULIN R U-100
2019/11/15 SUPPL-176(补充) Approval Labeling 901 REQUIRED Label for HUMULIN R U-100 and U-500
2019/11/15 SUPPL-175(补充) Approval Labeling STANDARD Label for HUMULIN R U-100 and U-500
2019/08/22 SUPPL-172(补充) Approval Labeling STANDARD Label for HUMULIN R U-100 and U-500
2018/11/06 SUPPL-168(补充) Approval Labeling STANDARD Label for HUMULIN R U-100 and U-500
2018/05/25 SUPPL-134(补充) Approval Labeling STANDARD Label for HUMULIN R U-100
2018/05/25 SUPPL-126(补充) Approval Manufacturing (CMC) STANDARD Label for HUMULIN R U-100
2016/07/08 SUPPL-153(补充) Approval Labeling STANDARD Label for HUMULIN R U-500
2016/06/24 SUPPL-155(补充) Approval Manufacturing (CMC) STANDARD
2016/02/26 SUPPL-154(补充) Approval Manufacturing (CMC) STANDARD
2015/12/29 SUPPL-152(补充) Approval Labeling STANDARD Label for HUMULIN R U-500
2015/12/29 SUPPL-135(补充) Approval Labeling STANDARD Label for HUMULIN R U-500
2015/10/08 SUPPL-151(补充) Approval Manufacturing (CMC) STANDARD
2015/02/25 SUPPL-150(补充) Approval Labeling 901 REQUIRED Label for HUMULIN R U-100
2014/10/30 SUPPL-149(补充) Approval Manufacturing (CMC) STANDARD
2014/09/23 SUPPL-148(补充) Approval Manufacturing (CMC) STANDARD Label for HUMULIN R U-500
2014/06/20 SUPPL-147(补充) Approval Manufacturing (CMC) STANDARD
2014/03/18 SUPPL-146(补充) Approval Manufacturing (CMC) STANDARD
2013/08/15 SUPPL-145(补充) Approval Manufacturing (CMC) STANDARD
2013/05/31 SUPPL-144(补充) Approval Manufacturing (CMC) STANDARD
2013/05/30 SUPPL-143(补充) Approval Manufacturing (CMC) STANDARD
2013/05/10 SUPPL-142(补充) Approval Manufacturing (CMC) STANDARD
2013/03/09 SUPPL-132(补充) Approval Labeling STANDARD Label for HUMULIN R U-100
2013/01/09 SUPPL-139(补充) Approval Manufacturing (CMC) STANDARD
2012/11/07 SUPPL-141(补充) Approval Manufacturing (CMC) STANDARD
2012/03/29 SUPPL-127(补充) Approval Manufacturing (CMC) STANDARD
2011/10/30 SUPPL-133(补充) Approval Labeling STANDARD
2011/03/25 SUPPL-120(补充) Approval Efficacy STANDARD
2011/03/21 SUPPL-124(补充) Approval Labeling STANDARD
2010/06/10 SUPPL-128(补充) Approval Labeling UNKNOWN
2007/09/10 SUPPL-114(补充) Approval Labeling STANDARD
2007/09/07 SUPPL-94(补充) Approval Labeling STANDARD
2007/08/22 SUPPL-95(补充) Approval Labeling STANDARD
2005/02/25 SUPPL-86(补充) Approval Manufacturing (CMC) STANDARD
2003/11/10 SUPPL-80(补充) Approval Manufacturing (CMC) STANDARD
2003/04/14 SUPPL-66(补充) Approval Labeling STANDARD
2003/02/10 SUPPL-78(补充) Approval Manufacturing (CMC) STANDARD
2003/02/10 SUPPL-67(补充) Approval Labeling STANDARD
2002/10/25 SUPPL-76(补充) Approval Manufacturing (CMC) STANDARD
2002/10/10 SUPPL-70(补充) Approval Manufacturing (CMC) STANDARD
2002/08/29 SUPPL-75(补充) Approval Manufacturing (CMC) STANDARD
2002/08/29 SUPPL-74(补充) Approval Manufacturing (CMC) STANDARD
2002/08/29 SUPPL-73(补充) Approval Manufacturing (CMC) STANDARD
2002/08/29 SUPPL-65(补充) Approval Manufacturing (CMC) STANDARD
2002/08/21 SUPPL-72(补充) Approval Manufacturing (CMC) STANDARD
2002/08/21 SUPPL-71(补充) Approval Manufacturing (CMC) STANDARD
2002/03/13 SUPPL-69(补充) Approval Manufacturing (CMC) STANDARD
2000/04/19 SUPPL-64(补充) Approval Manufacturing (CMC) STANDARD
1999/11/02 SUPPL-63(补充) Approval Manufacturing (CMC) STANDARD
1999/02/25 SUPPL-61(补充) Approval Manufacturing (CMC) STANDARD
1998/08/06 SUPPL-58(补充) Approval Manufacturing (CMC) STANDARD
1998/02/20 SUPPL-57(补充) Approval Manufacturing (CMC) STANDARD
1997/04/16 SUPPL-56(补充) Approval Manufacturing (CMC) STANDARD
1997/04/16 SUPPL-55(补充) Approval Labeling STANDARD
1997/01/28 SUPPL-54(补充) Approval Manufacturing (CMC) STANDARD
1996/07/26 SUPPL-52(补充) Approval Manufacturing (CMC) STANDARD
1996/07/26 SUPPL-50(补充) Approval Manufacturing (CMC) STANDARD
1996/07/10 SUPPL-51(补充) Approval Labeling STANDARD
1996/04/25 SUPPL-49(补充) Approval Manufacturing (CMC) STANDARD
1996/02/15 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
1996/02/14 SUPPL-47(补充) Approval Manufacturing (CMC) STANDARD
1995/11/09 SUPPL-46(补充) Approval Labeling STANDARD
1995/09/29 SUPPL-45(补充) Approval Labeling STANDARD
1995/03/09 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
1995/02/22 SUPPL-43(补充) Approval Labeling STANDARD
1994/06/14 SUPPL-39(补充) Approval Manufacturing (CMC) STANDARD
1994/03/31 SUPPL-42(补充) Approval Efficacy UNKNOWN
1994/01/11 SUPPL-37(补充) Approval Manufacturing (CMC) STANDARD
1993/05/10 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
1992/12/07 SUPPL-41(补充) Approval Manufacturing (CMC) STANDARD
1992/01/27 SUPPL-38(补充) Approval Labeling
1991/11/15 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1991/03/12 SUPPL-36(补充) Approval Labeling
1990/09/24 SUPPL-34(补充) Approval Manufacturing (CMC) STANDARD
1990/08/17 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
1989/02/01 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1989/01/23 SUPPL-32(补充) Approval Labeling
1988/07/29 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1988/06/10 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1988/03/24 SUPPL-29(补充) Approval Labeling
1987/10/27 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1987/07/28 SUPPL-21(补充) Approval Labeling
1987/07/13 SUPPL-23(补充) Approval Labeling
1987/07/10 SUPPL-26(补充) Approval Labeling
1987/05/07 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1986/09/15 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1986/05/28 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1986/04/10 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1985/03/08 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1984/12/26 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1984/11/23 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1984/07/25 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1984/02/28 SUPPL-12(补充) Approval Labeling
1984/01/26 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1983/10/12 SUPPL-8(补充) Approval Labeling
1983/08/24 SUPPL-7(补充) Approval Labeling
1983/03/14 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1983/01/31 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1983/01/27 SUPPL-4(补充) Approval Labeling
1982/12/02 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1982/12/02 SUPPL-1(补充) Approval Labeling
1982/10/28 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
004 7291132 2024/08/09 Y PDF格式**本条是由Drugfuture回溯的历史信息**
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
001 NR 2014/03/25**本条是由Drugfuture回溯的历史信息**
005 NR 2014/03/25**本条是由Drugfuture回溯的历史信息**
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本品无治疗等效药品
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